Entereg Laparoscopic Colon Resection Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Hartford Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Cubist Pharmaceuticals
Information provided by:
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT01258569
First received: December 9, 2010
Last updated: February 25, 2011
Last verified: February 2011

December 9, 2010
February 25, 2011
November 2010
April 2011   (final data collection date for primary outcome measure)
length of stay in days [ Time Frame: 7-10 days s/p discharge ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01258569 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Entereg Laparoscopic Colon Resection Study
Entereg Laparoscopic Colon Resection Study

Entereg (Alvimopan) is a peripherally acting mu-opioid receptor antagonist that has been shown to increase postoperative bowel function in patients after open bowel resection surgery. It has been proven safe and effective for short-term in-house treatment. At the present there are several Drug Use Utilization Evaluation studies reporting results involving the use of alvimopan (ENTEREG) in laparoscopic bowel resection patients. However, this study will be the first randomized, prospective, double-blind, placebo-controlled trial looking at this population. We propose that Entereg will decrease the length of stay by one day in the laparoscopic colon resection patient. We wish to perform a voluntary, double-blinded, placebo controlled study. We plan an enrollment population of 250 patients. Twelve milligrams of Entereg will be administered 30 minutes to 5 hours pre-op followed by 12 mg BID, up to 7 days or 15 total doses. The primary endpoint of the study will be length of stay. The time of GI-2 recovery (toleration of solid food and first bowel movement) and time to GI-3 recovery (toleration of solid food, and flatus or bowel movement) will be secondary endpoints.

Estimated Enrollment = 250, Study Start Date: November 2010, Estimated Study Completion Date: May 2012, Estimated Primary Completion Date: Nov 2011.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Laparoscopic Colonic Resection
  • Drug: Entereg
    Alvimopan (Entereg), an oral peripherally- acting mu-opioid receptor antagonist, is the first and only drug approved by the FDA to accelerate the time to upper and lower GI recovery in after partial large or small bowel resection surgery with primary anastomosis.
  • Drug: Entereg
    oral, 12 mg 30-300 min pre-op then BID up to 7 days (or 15 total doses)
  • Drug: placebo
    12 mg oral 30-300 min pre-op then BID up to 7 days (or 15 doses)
  • Active Comparator: Entereg
    Interventions:
    • Drug: Entereg
    • Drug: Entereg
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
April 2012
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

Subject is scheduled to undergo laparoscopic (straight or hand assisted) elective colon resection with primary anastamosis Subject is >18 years of age Subjects can be either male or female Negative pregnancy test (if patient is a premenopausal female) Medically stable as determined by the treating surgeon- i.e., subject has an American Society of Anesthesiologists Physical Status Score of I to III.

Subject understands the study procedures, agrees to participate in the study as per the study protocol, and has voluntarily provided informed consent Patients who will be receiving IV Opioid therapy post surgery for pain management.

Exclusion Criteria:

Subject is pregnant or lactating Subject is currently using opioids or has taken more than 3 doses of opioids (oral or parenteral) in the week prior to surgery.

Subject has complete bowel obstruction Subject is not able to understand the informed consent document or is unable to give informed consent Patients who will receive a thoracic epidural for pain management post surgery. Subject has any medical instability or any condition at screening/enrollment which, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject during the administration of study procedures.

Both
18 Years to 85 Years
No
Contact: Kristina Johnson, MD 860-548-7336 KJohnson@ctsurgical.com
United States
 
NCT01258569
JOHN002914HE
No
Kristina Johnson, MD, Hartford Hospital
Hartford Hospital
Cubist Pharmaceuticals
Not Provided
Hartford Hospital
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP